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A clinical trial and its ‘heroes’

by LUC RINALDI

Why you need to know about the international A4 clinical trial … and why you should participate, whether you’re in California, New York, Toronto or Melbourne. It could make the difference to your life.

Jim and Mary Lou Stanton are in no rush to leave.

Seated in beige leather recliners, the retired Newmarket, Ont., couple looks comfortable: Mary Lou battles the newspaper Sudoku puzzle, while her husband surveys the fourth-floor view of north Toronto. Only a few pieces of medical equipment around the bright room hint at why they’re here.

In the absence of these trials, we will not have new drugs and new treatments.

They’ve just finished one of their twice-monthly visits to the Toronto Memory Program, where they’re participating in one of the center’s many clinical trials researching Alzheimer’s disease.

“It’s important to do these trials, not just for myself, but for everyone up and coming,” says Mary Lou, a sprightly senior who was inspired to participate by the memory of her grandfather, who, late in life, “couldn’t remember his own name.”

The Stantons are a mild-mannered, unassuming pair, but Dr. Sharon Cohen describes them as the “heroes” of the field.

“In the absence of these trials, we will not have new drugs and new treatments,” says Cohen, director of the Toronto Memory Program, an expansive, 18-year-old clinic that houses Canada’s largest Alzheimer’s clinical trial program. “You have to go through this process.”

The ABCs of the A4 study

One of the newest of these processes underway at the Memory Program is the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Study, also known as the A4 Study. The landmark three-year study hopes to attract 1,000 cognitively healthy participants over 65 from the United States, Canada and Australia to help understand Alzheimer’s link to amyloid, an abnormal sticky protein that begins to build up in the brain at least 10 years before the disease’s symptoms manifest.

First, researchers at 60 sites, mainly in the United States, have to find as many as 10,000 volunteers to be screened for the 39-month trial – screening started in September – to get the 1,000 participants required.

It will hopefully invigorate the field, because people without symptoms can come forward.

Through monthly infusions of a drug called solanezumab and regular cognitive testing, the collaborative effort — the A4 is a $140-million joint project among the Alzheimer’s Association, the National Institute of Aging, private and philanthropic organizations — aims to both confirm that amyloid buildup is a cause of Alzheimer’s and pinpoint a way to fight those buildups.

The principal investigator fo the trial is Reisa Sperling, MD, the director ofResearchers from the Center for Alzheimer Research and Treatment (CART) at Brigham and Women’s Hospital in Boston.

“The A4 study has really opened people’s eyes because it’s a bigger and different population now,” Cohen says.

“It’s younger people than those who have Alzheimer’s — people who have seen the disease in their family, who are proactive about their health and who want to know their risks… It will hopefully invigorate the field, because people without symptoms can come forward.”

That wasn’t always the case in amyloid trials, explains Joanne Lawrence, the senior clinical trials coordinator at Sunnybrook Health Sciences Centre’s memory unit, which is also a Canadian participant in the A4.

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